Use of Biomaterials as Desensitizer Agents

NCT02770573 | Unknown DMC

• 1 other identifier: DH 2304/CE
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: to investigate the clinical effectiveness over 12 weeks of three different biomaterials, nano-hydroxyapatite based, in the therapy of the dental sensitivity. Methods: The study is designed as a randomized clinical trial comparing: 1) Cavex Bite\&White ExSense, 2) Teethmate™ Desensitizer , 3) Ghimas Dentin Desensitizer. The pain experience was generated by a cold stimulus directly to a sensitive tooth surface and assessed using the Visual Analogue Scale (VAS). The response was recorded before the application of the materials (PRE-1), immediately after (POST-1), at 1-week (POST-2), 4-weeks (POST-3) and 12-week controls (POST-4).

Conditions

Dentin Sensitivity

Keywords

nano-hydroxyapatite

Outcome Measures

Primary Outcomes (1)

• Evaluation of change of dentinal hypersensitivity after treatment

  The pain experience was assessed by a Visual Analogue Scale (VAS) using the methodology. The VAS scale consisted of a horizontal line that was 100 mm long, on which 'no pain' was marked on the right-hand extremity and 'unbearable pain' on the other. The patients expressed the intensity of the pain experienced by placing a mark at any point along the continuum. The distance, expressed in millimetres, from the right edge of 'no pain' was used as the VAS score. Each patient was asked to rate the perception of discomfort after the application of air via a dental syringe at 45-60 psi, 1 cm at the cervical third of the tooth after removing supragingival plaque with a low- speed handpiece with pumice powder and without fluoride. The adjacent teeth were covered by cotton rolls. The stimulus was delivered until reaction or up to a maximum duration of 10 s by the same examiner with the same equipment yielding similar air pressure each time.

  before the treatment (PRE-1), immediately after (POST-1), after 1 week (POST-2), 4 weeks (POST-3), and 12 weeks (POST-4).

Study Arms (1)

Patients with dentin hypersensitivity

EXPERIMENTAL

Patients with evident clinical signs of dentin hypersensitivity The following dental materials will be used following the manufacturers' instructions: Cavex Bite\&White ExSense; Kuraray Teethmate™ Desensitizer; Ghimas Dentin Desensitizer. In view of the treatment with the desensitizing agents, teeth were randomly assigned into four groups. The application of the materials will be made only once. The effectiveness will be evaluated: immediately after application and after 1, 4, 12 weeks.

Other: Cavex Bite&White ExSense; Other: Kuraray Teethmate™ Desensitizer; Other: Ghimas Dentin Desensitizer

Interventions

Cavex Bite&White ExSense OTHER

a water-based mint aroma gel containing hydroxyapatite and potassium nitrate.

Patients with dentin hypersensitivity

Kuraray Teethmate™ Desensitizer OTHER

Calcium-Phosphate-based powder and a liquid mainly water-based.

Patients with dentin hypersensitivity

Ghimas Dentin Desensitizer OTHER

a fluid desensitizing gel with 30% of nano-hydroxyapatite, added to 70:100 thousandths of micron-sized crystals of nano- hydroxyapatite.

Patients with dentin hypersensitivity

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients will be considered suitable for the study if they had sensitive teeth showing abrasion, erosion, or recession with the exposure of the cervical dentine;

You may not qualify if:

• teeth with subjective or objective evidence of carious lesions, pulpitis, restorations, premature contact, cracked enamel, active periapical infection, or which had received periodontal surgery or root-planning up to 6 months prior to the investigation will be excluded from the study
• professional desensitizing therapy during the previous 3 months, or use of desensitizing toothpaste in the last 6 weeks.
• Patients will be also excluded if they will be under significant medication that could interfere with pain perception (e.g., antidepressants, anti-inflammatory drugs, sedatives, and muscle relaxants).

Sponsors & Collaborators

• Università degli Studi di Sassari: lead

Study Sites (1)

Complex Operative Unit of Dentistry

Sassari, 07100, Italy

Location

Related Publications (2)

• Milia E, Castelli G, Bortone A, Sotgiu G, Manunta A, Pinna R, Gallina G. Short-term response of three resin-based materials as desensitizing agents under oral environmental exposure. Acta Odontol Scand. 2013 May-Jul;71(3-4):599-609. doi: 10.3109/00016357.2012.700063. Epub 2012 Aug 15.

  PMID: 22891890 BACKGROUND

• Pinna R, Bortone A, Sotgiu G, Dore S, Usai P, Milia E. Clinical evaluation of the efficacy of one self-adhesive composite in dental hypersensitivity. Clin Oral Investig. 2015 Sep;19(7):1663-72. doi: 10.1007/s00784-014-1390-3. Epub 2015 Jan 23.

  PMID: 25609032 BACKGROUND

Related Links

• Effectiveness of nano-hydroxyapatite toothpaste in reducing dentin hypersensitivity: a double-blind randomized controlled trial.

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Egle Milia, Prof

  Università degli Studi di Sassari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 12, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2017
• Last Updated: April 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)